Infusion system with concurrent TPN/insulin infusion

ABSTRACT

An infusion system to provide concurrent TPN/insulin infusion including: a fluid administration set having a primary line in fluid communication with the TPN source, a secondary line in fluid communication with the insulin source, and a common outlet line; a pump operable to removably receive the fluid administration set, the pump being operable to concurrently move the TPN solution through the primary line in response to a TPN solution flow rate signal and the insulin solution through the secondary line in response to an insulin solution flow rate signal; and a flow controller operable to provide the TPN solution flow rate signal and the insulin solution flow rate signal to the pump. The flow controller is further operable to vary the TPN solution flow rate signal and the insulin solution flow rate signal to vary a ratio of TPN solution to insulin solution provided to the common outlet line.

TECHNICAL FIELD

The present invention relates to medical devices. More specifically, theinvention relates to infusion systems with concurrent total parenteralnutrition (TPN)/insulin infusion.

BACKGROUND OF THE INVENTION

Infusion pumps are medical devices that deliver fluids, includingnutrients and medications such as antibiotics, chemotherapy drugs, andpain relievers, into a patient's body in controlled amounts. Many typesof pumps, including large volume, patient-controlled analgesia (PCA),elastomeric, syringe, enteral, and insulin pumps, are used worldwide inhealthcare facilities such as hospitals, and in the home. Clinicians andpatients rely on pumps for safe and accurate administration of fluidsand medications.

Total parenteral nutrition (TPN) is used to feed a person intravenouslywhen the gastrointestinal tract is nonfunctional or impaired, so thatnutrition cannot be provided to the patient through eating. TPN solutioncan include sugar, carbohydrates, proteins, lipids, electrolytes, traceelements, and various combinations thereof, as required for a particularpatient.

Unfortunately, hyperglycemia is one complication associated withadministration of TPN. Recent studies have highlighted thathyperglycemia is associated with increased risk of cardiaccomplications, infection, systemic sepsis, acute renal failure, anddeath for patients receiving TPN. Glycemic control in these patients iscrucial in maintenance of tolerable blood glucose levels, a fact furthersubstantiated by correlated adverse outcomes.

In present practice, TPN solution administration is tapered to 50% ofthe required dosing for the patient to minimize hyperglycemia and avoidglucose shock. Insulin is premixed in the same IV bag or container withthe TPN solution based on calculated requirements for the patient,adding to clinician time and risk of error. Insulin dosing also requiresmodulation based on monitored glucose levels during infusion.Subcutaneous insulin infusions can be administered to compensate foradvancing hyperglycemia. For hypoglycemic situations, increased TPN (andspecifically dextrose) delivery is indicated. Thus, infusion of both TPNand insulin as presently practiced is complex and time consuming.

It would be desirable to have an infusion system with concurrentTPN/insulin infusion that would overcome the above disadvantages.

SUMMARY OF THE INVENTION

One aspect of the present invention provides an infusion system for apatient for use with a TPN source of TPN solution and separate insulinsource of insulin solution to provide concurrent TPN/insulin infusion,the infusion system including: a fluid administration set having aprimary line in fluid communication with the TPN source, a secondaryline in fluid communication with the insulin source, and a common outletline in fluid communication with the primary line, the secondary line,and the patient; a pump operable to removably receive the fluidadministration set, the pump being operable to concurrently move the TPNsolution through the primary line in response to a TPN solution flowrate signal and the insulin solution through the secondary line inresponse to an insulin solution flow rate signal; and a flow controlleroperable to provide the TPN solution flow rate signal and the insulinsolution flow rate signal to the pump. The flow controller is furtheroperable to vary the TPN solution flow rate signal and the insulinsolution flow rate signal to vary a ratio of TPN solution to insulinsolution provided to the patient from the common outlet line.

Another aspect of the present invention provides a method toconcurrently deliver a TPN solution from a TPN source and an insulinsolution from separate insulin source, the method including: providing afluid administration set having a primary line, a secondary line, acommon outlet line, and a pumping/mixing chamber between and in fluidcommunication with the primary line, the secondary line, and commonoutlet line; connecting the primary line to the TPN source; connectingthe secondary line to the insulin source; allowing TPN fluid into thepumping/mixing chamber; allowing insulin solution into thepumping/mixing chamber; mixing the TPN solution and the insulin solutionto generate an infusion mixture before the common outlet; with apositive displacement pump, driving the TPN solution through the commonoutlet line at a TPN dose rate and with a positive displacement pump,driving the insulin solution through the common outlet line at aninsulin dose rate; and varying at least one of the TPN dose rate and theinsulin dose rate to vary a ratio of TPN solution to insulin solution inthe infusion mixture.

The foregoing and other features and advantages of the invention willbecome further apparent from the following detailed description of thepresently preferred embodiments, read in conjunction with theaccompanying drawings. The detailed description and drawings are merelyillustrative of the invention rather than limiting, the scope of theinvention being defined by the appended claims and equivalents thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of an infusion system with concurrentTPN/insulin infusion in accordance with the present invention;

FIG. 1A is a block diagram of an infusion system with concurrentTPN/insulin infusion in accordance with one embodiment of the presentinvention;

FIG. 2 is an operating mode option screen for an infusion system withconcurrent TPN/insulin infusion in accordance with the presentinvention;

FIGS. 3A-3C are infusion profile selection screens for an infusionsystem with concurrent TPN/insulin infusion in accordance with thepresent invention;

FIGS. 4A-4I are TPN infusion setup screens for an infusion system withconcurrent TPN/insulin infusion in accordance with the presentinvention;

FIGS. 5A-5F are insulin infusion setup screens for an infusion systemwith concurrent TPN/insulin infusion in accordance with the presentinvention;

FIG. 6 is a confirmation screen for an infusion system with concurrentTPN/insulin infusion in accordance with the present invention;

FIGS. 7A-7J are operational screens for an infusion system withconcurrent TPN/insulin infusion in accordance with the presentinvention; and

FIG. 8 is a flowchart of a method for concurrently administering a TPNsolution and an insulin solution in accordance with the presentinvention.

FIG. 9 is a flowchart of another method for concurrently delivering aTPN solution and an insulin solution in accordance with the presentinvention.

Like elements share like reference numbers throughout the variousfigures.

DETAILED DESCRIPTION OF PRESENTLY PREFERRED EMBODIMENTS

FIG. 1 is a block diagram of an infusion system with concurrentTPN/insulin infusion in accordance with the present invention. Theinfusion system 100 for a patient 90 is for use with a TPN source orsource container 102 of TPN solution and a separate insulin source orsource container 104 of insulin solution. The infusion system 100 canconcurrently deliver the TPN solution and the insulin solution, withoutrequiring that the insulin be premixed in the same IV bag or containeras the TPN solution or be administered by syringe boluses subcutaneouslyor a different pump or flow controller.

The infusion system 100 includes a fluid administration set 108, a pump120 operable to removably receive the administration set 108, and a flowcontroller 130 operable to control flow through the administration set108. The administration set 108 has a primary line 112 in fluidcommunication with the TPN source 102, a secondary line 114 in fluidcommunication with the insulin source 104, and a common outlet line 116connected to and in operative fluid communication with the primary line112, the secondary line 114, and the patient 90. The infusion system 100can optionally include a glucose sensor 140 for providing feedback tothe flow controller 130 and/or a user interface 200 providing inputand/or output to a user 202. The user interface 200 can be integral toor can be separate from the infusion system 100. In one example, theuser interface 200 is wired into the infusion system 100. In anotherexample, the user interface 200 communicates wirelessly with theinfusion system 100. The user 202 can be the patient 90 themselves or acaregiver of the patient 90.

In one embodiment, the pump 120 is a positive displacement pump and hasa drive mechanism 105 that is operable on the fluid administration set108 to concurrently move the TPN solution through the primary line 112to the outlet line 116 in response to a TPN solution flow rate signal122 and the insulin solution through the secondary line 114 to theoutlet line 116 in response to an insulin solution flow rate signal 124.The flow controller 130 is operable to provide the TPN solution flowrate signal 122 and the insulin solution flow rate signal 124 to thedrive mechanism 105 of the pump. The flow controller 130 is furtheroperable to vary the TPN solution flow rate signal 122 and the insulinsolution flow rate signal 124 to vary a ratio of TPN solution to insulinsolution provided to the common outlet line 116.

As best seen in FIG. 1A, in one embodiment the fluid administration set108 comprises a cassette 110 including a primary inlet 113 joining aprimary fluid passageway 112A in the cassette 110 into fluidcommunication with the primary line 112, a secondary inlet 117 joining asecondary fluid passageway 114A in the cassette into fluid communicationwith the secondary line 114, an outlet 109 in fluid communication withthe outlet line 116, and a pumping/mixing chamber 106 covered by aresilient flexible membrane 107 and in fluid communication with theprimary fluid passageway 112A, the secondary fluid passageway 114A, andthe outlet 109. The drive mechanism 105 includes a motor M driving aplunger P into the membrane 107 covering the pumping/mixing chamber 106in a reciprocating manner in response to a motor drive signal 123 fromthe flow controller 130. In addition, the flow controller 130 providescontrol signals 122, 124 and 125 respectively to operate a primary inletvalve 115, a secondary inlet valve 119 and an outlet valve 121 so as tomix and displace fluid from the pumping/mixing chamber 106 through theoutlet 109 into the outlet line 116 with each cycle of the plunger P. Inone embodiment, the motor M is a stepper motor that extends and retractsthe plunger P to displace fluid from the pumping/mixing chamber 106.Therefore, the pump 120 acts on the cassette 110 and is operable toconcurrently move the TPN solution through the primary line 112 inresponse to a TPN solution flow rate signal 122 and the insulin solutionthrough the secondary line 114 in response to an insulin solution flowrate signal 124. The flow controller 130 is operable to provide to thepump 120 the TPN solution flow rate signal 122 and the insulin solutionflow rate signal 124. The flow controller 130 is further operable tovary the TPN solution flow rate signal 122 and the insulin solution flowrate signal 124 to vary a ratio of TPN solution to insulin solutionprovided from the common outlet 116 to the patient 90. Thus, the flowcontroller 130 can vary the ratio of TPN solution to insulin solution inthe infusion solution with time, as desired for a particularapplication. In one embodiment, the pump 120 is a Plum A+™ generalpurpose infusion system available from Hospira, Inc. of Lake Forest,Ill. The cassette 110 is also available from Hospira, Inc. under thetrademark PLUMSET™.

The TPN source 102 of TPN solution and the insulin source 104 of insulinsolution can be any containers operable to hold liquid, such as anintravenous (IV) bag, rigid IV container, a syringe, or the like. TheTPN solution can be any solution for total parenteral nutrition (TPN)and can include sugar, carbohydrates, proteins, lipids, electrolytes,trace elements, and the like, as required for a particular application.The insulin solution can include insulin in a solution such as in asaline solution, TPN solution, or the like. The concentration of the TPNsolution and the insulin solution remain constant during the concurrentTPN/insulin infusion.

The pump 120 can be any pump operable to receive a fluid administrationset in general or a cassette in particular. In one example, the cassetteis a disposable cassette. In one example, the pump 120 pressurizes theprimary line 112 and the secondary line 114, and valves in each of theprimary line 112 and the secondary line 114 of the disposable cassette110 govern the flow rate in each of the primary line 112 and thesecondary line 114. In another example, the pump 120 varies impellerspeed for impellers in each of the primary line 112 and the secondaryline 114 to govern the flow rate in each of the primary line 112 and thesecondary line 114.

Those skilled in the art will appreciate that the flow controller 130can include a processor and a memory coupled to the processor. Thememory can contain programming code executable by the processor to carryout a method of concurrent TPN/insulin infusion as described herein.

The flow controller 130 can provide a TPN ramp phase, a TPN continuousphase, a TPN taper phase, and/or a TPN Keep Vein Open (KVO) phase duringthe concurrent TPN/insulin infusion as desired for a particularapplication. One skilled in the art will recognize in view of thepresent disclosure that the TPN KVO phase is really just a special caseof a Continue at the Same or Different Rate TPN phase.

The TPN ramp phase ramps the TPN flow rate through the primary line 112from zero to the TPN flow rate for the TPN continuous phase, such as canbe used at the beginning of the concurrent TPN/insulin infusion. Anexemplary TPN ramp phase is illustrated at Ramp portion 610 of FIG. 6.Referring to FIG. 1, for the TPN ramp phase the flow controller 130 canramp the TPN solution flow rate signal from a value corresponding to aTPN dose rate of zero to a value corresponding to a continuous phase TPNdose rate. In one embodiment, the flow controller 130 can maintain theinsulin solution flow rate signal 124 at a value corresponding to aninsulin dose rate of zero during the TPN ramp phase. In anotherembodiment, the flow controller 130 can maintain the insulin solutionflow rate signal 124 as a selected fraction of the TPN solution flowrate signal 122 during the TPN ramp phase to maintain the ratio of theTPN solution to the insulin solution as constant during the TPN rampphase. In yet another embodiment, the flow controller 130 can maintainthe insulin solution flow rate signal 124 at a value corresponding to acontinuous phase insulin dose rate during the TPN ramp phase.

The TPN continuous phase can maintain the TPN flow rate through theprimary line 112 as constant. An exemplary TPN continuous phase isillustrated at Continuous portion 620 of FIG. 6. Referring to FIG. 1,for the TPN continuous phase the flow controller and can maintain theTPN solution flow rate signal 122 at a value corresponding to acontinuous phase TPN dose rate and to maintain the insulin solution flowrate signal 124 at a selected fraction of the TPN solution flow ratesignal 122 during the TPN continuous phase. Those skilled in the artwill appreciate that the insulin solution flow rate signal 124 can beadjusted during the TPN continuous phase as desired to manually orautomatically adjust for measured glucose levels of the patient.

The TPN taper phase can taper the TPN flow rate through the primary line112 from the TPN flow rate for the TPN continuous phase, such as can beused at the end of the concurrent TPN/insulin infusion. An exemplary TPNtaper phase is illustrated at TPN Taper option 306 of FIG. 3A. Referringto FIG. 1, for the TPN taper phase the flow controller can taper the TPNsolution flow rate signal 122 from a value corresponding to a continuousphase TPN dose rate to a value corresponding to a TPN dose rate of zeroduring the TPN taper phase. In one embodiment, the flow controller 130can maintain the insulin solution flow rate signal 124 at a valuecorresponding to an insulin dose rate of zero during the TPN taperphase. In another embodiment, the flow controller 130 can maintain theinsulin solution flow rate signal 124 as a selected fraction of the TPNsolution flow rate signal 122 to maintain the ratio of the TPN solutionto the insulin solution as constant during the TPN taper phase. In yetanother embodiment, the flow controller 130 can maintain the insulinsolution flow rate signal 124 at a value corresponding to a continuousphase insulin dose rate during the TPN taper phase.

The TPN Keep Vein Open (KVO) phase can step the TPN flow rate throughthe primary line 112 from the TPN flow rate for the TPN continuous phaseto zero, such as can be used at the end of the concurrent TPN/insulininfusion. An exemplary TPN KVO phase is illustrated at KVO portion 630of FIG. 6. Referring to FIG. 1, for the TPN KVO phase the flowcontroller 130 can decrease the TPN solution flow rate signal 122 from avalue corresponding to a continuous phase TPN dose rate to a valuecorresponding to a Keep Vein Open (KVO) TPN dose rate after a TPNcontinuous phase. Again, one skilled in the art will recognize in viewof the present disclosure that the TPN KVO phase is really just aspecial case of a Continue at the Same or Different Rate TPN phase.

The insulin flow rate can be adjusted by the user 202 on the fly, i.e.,as the concurrent TPN/insulin infusion proceeds, as illustrated in FIGS.7E-7H. Referring to FIG. 1, the flow controller 130 can vary the insulinsolution flow rate signal 124 from a first insulin solution flow ratesignal to a second insulin solution flow rate signal in response toinput of the second insulin solution flow rate signal by a user 202.

The insulin flow rate can also be adjusted in response to currentglucose measurements for the patient 90. The infusion system 100 canalso include a glucose sensor 140 operably connected to the patient 90to monitor glucose level and to provide a glucose signal 92 to the flowcontroller 130. In one embodiment, the flow controller 130 is furtheroperable to vary the insulin solution flow rate signal 124 from a firstinsulin solution flow rate signal to a second insulin solution flow ratesignal in response to the glucose signal 92. In one embodiment, theglucose sensor 140 can provide the glucose signal 92 to an insulintherapy calculation system or algorithm, which then automaticallyprograms (auto-programs or auto-populates) the flow controller 130 andpopulates a user interface 200 with updated delivery parameters, such asrate, volume and duration, and the like.

The infusion system 100 can also include a user interface 200 operablyconnected to the flow controller 130 to provide information for and/orreceive instructions from the user 202. The user interface 200 isoperable to display a TPN/Insulin Infusion Plot portion having a TPNInfusion profile and an Insulin Infusion profile. An exemplaryTPN/Insulin Infusion Plot is illustrated at TPN/Insulin Infusion Plotportion 700 of FIG. 7A. Referring to FIG. 1, in one embodiment, the userinterface 200 is further operable to display an Infusion Progressionindicator on the TPN/Insulin Infusion Plot portion, the InfusionProgression indicator being operable to indicate a current state of theconcurrent TPN/insulin infusion. In one embodiment, the user interface200 is further operable to display an infusion portion selected from thegroup consisting of a Ramp portion, a Continuous portion, a Taperportion, and a KVO/continue rate portion. In one embodiment, the userinterface 200 is a touch screen. In another embodiment, the userinterface 200 is a combination of the electromechanical switches and agraphical display.

FIGS. 2-7 illustrate exemplary screens on the user interface of aninfusion system with concurrent TPN/insulin infusion in accordance withthe present invention. For clarity of illustration, a hand icon in FIGS.2-7 indicates interaction of the user 202 with the user interface 200.

FIG. 2 is an operating mode option screen for an infusion system withconcurrent TPN/insulin infusion in accordance with the presentinvention. The user 202 can select Tap to Program TPN key 204 on theuser interface 200 to initiate programming of a concurrent TPN/insulininfusion.

FIGS. 3A-3C are infusion profile selection screens for an infusionsystem with concurrent TPN/insulin infusion in accordance with thepresent invention. The user can select a desired profile for concurrentTPN/insulin infusion.

Referring to FIG. 3A, the user interface 200 displays a TPN portion 300for selecting the TPN infusion profile and an insulin portion 320 forselecting concurrent insulin infusion. In this example, the TPN portion300 is associated with the primary line A and the insulin portion 320 isassociated with the secondary line B. The TPN portion 300 can include aTPN Ramp option 302, a TPN Continuous option 304, and a TPN Taper option306. The insulin portion 320 can include an Infusion option 322. In thisexample, the TPN Continuous option 304 is selected by default, and theTPN Ramp option 302, the TPN Taper option 306, and the Infusion option322 are unselected. The user 202 selects the TPN Ramp option 302 andleaves the TPN Taper option 306 unselected. In this example, theunselected options are grayed out and the selected options arehighlighted on the user interface 200.

In one embodiment, the TPN continuous option 304 is selected by defaultso that the user does not have to select the TPN continuous option 304.In one embodiment, the TPN Ramp option 302, the TPN Taper option 306,and the Infusion option 322 are unselected by default. Those skilled inthe art will appreciate that the selected an unselected options can beprovided in any combination as desired for a particular application.

Referring to FIG. 3B, the user 202 selects the Infusion option 322 inthe infusion portion 320. Referring to FIG. 3C, the user 202 hascompleted selection of the concurrent TPN/insulin infusion profile andselects a Done key 330 to close out the profile selection and proceed toTPN infusion setup. The TPN Ramp option 302, the TPN Continuous option304, and the Infusion option 322 are enabled as indicated by thehighlighting.

FIGS. 4A-4I are TPN infusion setup screens for an infusion system withconcurrent TPN/insulin infusion in accordance with the presentinvention.

Referring to FIG. 4A, the user interface 200 displays a TPN InfusionSetup portion 380 and a TPN Volume portion 410 displaying potentialvolumes of TPN solution available for selection, i.e., potential TPNsolution container volumes. In this example, the user 202 selects 2 L asthe TPN solution volume to match the TPN solution container volume ofthe TPN source connected to the disposable cassette.

Referring to FIG. 4B, the user interface 200 displays a TPN ContinuousPhase portion 390 and a TPN Dose Unit portion 420. The TPN ContinuousPhase portion 390 includes a TPN Phase Being Programmed indicator 392and a TPN Solution Volume indicator 394. The TPN Dose Unit portion 420displays potential dose units for selection. In this example, the user202 selects mL/kg/day as the dose unit.

Referring to FIG. 4C, the user interface 200 displays a TPN Dose Unitindicator 396 in the TPN Continuous Phase portion 390, and a Desired TPNDose box 432 and entry keypad 434 in the TPN Dose portion 430. The usercan enter the desired TPN dose to be delivered during the TPN continuousphase in the Desired TPN Dose box 432 using the entry keypad 434.Referring to FIG. 4D, the desired TPN dose appears in the Desired TPNDose box 432 and the user 202 selects a Done key 436 to close out theTPN Dose & Unit selection and proceed to a Weight selection.

Referring to FIG. 4E, the user interface 200 displays a TPN Doseindicator 398 in the TPN Continuous Phase portion 390, and a Weight box442 and entry keypad 444 in the TPN Dose Unit portion 440. The user canenter the weight of the patient in the Weight box 442 using the entrykeypad 444. Referring to FIG. 4F, the weight appears in the Weight box442 and the user 202 selects a Done key 446 to close out the Weightselection and proceed to TPN Duration selection.

Referring to FIG. 4G, the user interface 200 displays a Weight indicator400 and a TPN Rate indicator 402 in the TPN Continuous Phase portion390. The numerical value for the rate in the TPN Rate indicator 402 isautomatically calculated based on the dose, dose unit, and weight. Theuser interface 200 also displays a TPN Duration box 452 and entry keypad454 in the TPN Dose Unit portion 450. The user can enter the desired TPNdose duration of the TPN continuous phase the TPN Duration box 452 usingthe entry keypad 454. Referring to FIG. 4H, the desired TPN dose appearsin the TPN Duration box 452 and the user 202 selects a Done key 456 toclose out the TPN Duration selection and proceed to TPN Optionsselection.

Referring to FIG. 4I, the user interface 200 displays a TPN Durationindicator 404 and a TPN Volume to Be Infused (VTBI) indicator 406 in theTPN Continuous Phase portion 390. The numerical value for the VTBI inthe VTBI indicator 406 is automatically calculated based on the durationand rate. The user interface 200 also displays a TPN Continuous ProgramOptions portion 460 including an End of Infusion Action section 462, aNearing End of Infusion Alarm section 464, and an Air-in-Line Alarmsection 468. The End of Infusion Action section 462 includes options tobe performed after the TPN infusion is complete, such as a Keep VeinOpen (KVO) option with rate value input to continue infusion at areduced rate, a Continue Rate option to continue infusion at theprevious rate, and a Stop option to end the infusion. In this example,the Keep Vein Open (KVO) option with a rate value of one mL/hr isselected. The Nearing End of Infusion Alarm section 464 includesenabling or disabling (On or Off) an optional alarm as the TPN infusionnears completion, with a value time input for the amount of time beforethe End of Infusion alarm is to occur. In this example, the Nearing Endof Infusion Alarm is turned off. The Air-in-Line Alarm section 468provides an air volume input value at which the Air-in-Line Alarm is tooccur. In this example, the Air-in-Line Alarm is set to occur at anerror volume of 250 mcL. The user 202 selects a Next key 470 to closeout the Options selection and proceed to insulin infusion setup.

FIGS. 5A-5F are insulin infusion setup screens for an infusion systemwith concurrent TPN/insulin infusion in accordance with the presentinvention.

Referring to FIG. 5A, the user interface 200 displays an InsulinInfusion Setup portion 480 and an Insulin Concentration portion 510displaying potential concentrations of insulin solution available forselection. In this example, the user 202 selects 1 unit/mL concentrationas the insulin solution concentration.

Referring to FIG. 5B, the user interface 200 displays an InsulinSolution Concentration indicator 482 in the Insulin Infusion Setupportion 480 and potential volumes of insulin solution available forselection, i.e., potential insulin solution container volumes, in anInsulin Volume portion 520. In this example, the user interface 200switches from the Insulin Concentration portion to the Insulin Volumeportion 520 automatically when the user selects the insulin solutionconcentration in the Insulin Concentration portion. In this example, theuser 202 selects a 100 mL as the insulin solution volume to match theinsulin solution container volume of the insulin source connected to thedisposable cassette.

Referring to FIG. 5C, the user interface 200 displays an InsulinSolution Concentration indicator 584 and an Insulin Solution Volumeindicator 586 in an Insulin Infusion portion 490, which also includesthe Insulin Duration indicator 504 showing the previously entereddesired TPN dose duration (being the same as the desired insulin doseduration). The user interface 200 also displays a Desired Insulin Dosebox 532 and entry keypad 534 in the Insulin Dose portion 530. The doseunits are automatically selected to be the standard Units (of insulin)/Lof TPN. The user can enter the desired insulin dose to be deliveredduring the TPN continuous phase in the Desired Insulin Dose box 532using the entry keypad 534. Referring to FIG. 5D, the desired insulindose appears in the Desired Insulin Dose box 532 and the user 202selects a Done key 536 to close out the Insulin Dose & Unit selectionand proceed to Insulin Options selection.

Referring to FIG. SE, the user interface 200 displays an Insulin Volumeto Be Infused (VTBI) indicator 506 and an Insulin Rate indicator 508 inthe Insulin Continuous Phase portion 490. The insulin VTBI and insulinrate are automatically calculated from the insulin duration, the TPNVTBI, and the TPN rate entered and/or calculated previously. The userinterface 200 also displays an Insulin Infusion Options portion 540providing additional options for insulin administration and rate. Theinsulin infusion options allow independently titrating the insulindelivery or linking the insulin delivery to the TPN delivery in waysthat cannot be achieved if the TPN solution and insulin solution arepremixed in the same IV bag. When the Only When TPN in Continuous Phasebutton 542 is selected, insulin infusion is only provided when the TPNis in the continuous phase. In this example, the user 202 is selectingthe Ramp and Taper button 544.

Referring to FIG. SF, the Ramp and Taper button 544 is selected and theOnly When TPN in Continuous Phase button 542 is deselected. During theramp and taper portion of the infusion, the insulin infusion rate can belinked to the TPN infusion rate by selecting a Rate Linked to TPN button546 or can be maintained at the insulin infusion rate used in the TPNcontinuous phase by selecting the Keep Continuous Phase Rate button 548.In this example, the Rate Linked to TPN button 546 is selected. The user202 selects a Next key 550 to close out the Insulin Infusion Optionsselection and proceed to infusion confirmation.

FIG. 6 is a confirmation screen for an infusion system with concurrentTPN/insulin infusion in accordance with the present invention. The usercan check the confirmation screen to verify that the TPN infusionparameters and insulin infusion parameters have been entered andcalculated as desired.

The user interface 200 displays a confirmation screen 600 having a Rampportion 610, a Continuous portion 620, and a KVO portion 630. Theconfirmation screen 600 further includes TPN infusion profiles 612, 622,632 and insulin infusion profiles 614, 624, 634. In this example basedon the previously entered parameters, the TPN infusion ramp 612increases from zero to 133.33 mL/hr over 2.0 hours. The insulin infusionramp 614, linked to the TPN infusion, increases from zero to 1.33 mL/hrover 2.0 hours. In this example, ramping is preset to 2 hours, but canalso be altered as needed for a particular application. For the next 12hours after the infusion ramp, the TPN continuous infusion 622 ismaintained at 133.33 mL/hr and the insulin continuous infusion 624 ismaintained at 1.33 mL/hr. Until stopped after the continuous infusion,the TPN KVO infusion 632 is maintained at 1.0 mL/hr and the insulin KVOinfusion 634 is zero. The user 202 selects a Start key 650 to start theconcurrent TPN/insulin infusion.

FIGS. 7A-7J are operational screens for an infusion system withconcurrent TPN/insulin infusion in accordance with the presentinvention. The operational screens display numerical and graphicalinformation for the concurrent TPN/insulin infusion as planned and asthe infusion proceeds.

Referring to FIG. 7A, the user interface 200 displays an Infusion Phaseindicator 701, a TPN/Insulin Infusion Plot portion 700, a TPN Infusionportion 740, and an Insulin Infusion portion 760. The Infusion Phaseindicator 701 displays the current phase of the concurrent TPN/insulininfusion.

The TPN/Insulin Infusion Plot of the TPN/Insulin Infusion Plot portion700 displays infusion profiles and visual status for two concurrent drugdeliveries. The TPN/Insulin Infusion Plot portion 700 has a Ramp portion710 with a Ramp Phase Time Remaining indicator 712, a Continuous portion720 with a Continuous Phase Time Remaining indicator 722, and a KVOportion 730 with a KVO Phase Time Remaining indicator 732. A TPNInfusion profile 702 and an Insulin Infusion profile 704 display theinjection rates of the TPN infusion and Insulin Infusion with time overthe concurrent TPN/insulin infusion. An Infusion Progression indicator706 illustrates the current state of the concurrent TPN/insulininfusion. In this example, the TPN/Insulin Infusion Plot portion 700preceding the Infusion Progression indicator 706 is grayed out.

The TPN Infusion portion 740 includes a Line A Activity indicator 742(which can be animated to indicate that the Line A is pumping), a TPNSolution Volume indicator 744, a TPN Dose indicator 746, a TPN Dose Rateindicator 748, and a TPN VTBI indicator 750. The Insulin Infusionportion 760 includes a Line B Activity indicator 762 (which can beanimated to indicate that the Line A is pumping), an Insulin SolutionVolume indicator 764, an Insulin Dose indicator 766, an Insulin Rateindicator 768, and an Insulin VTBI indicator 770. The values presentedin the TPN Infusion portion 740 and the Insulin Infusion portion 760 areupdated as the concurrent TPN/insulin infusion proceeds. The valuesillustrated in the example of FIG. 7A are at the beginning of the rampphase of the concurrent TPN/insulin infusion. The infusion rate of eachline will gradually ramp over the next 2 hours until the continuousphase is reached.

Referring to FIG. 7B, this example shows the user interface 200 with1:15 (hh:mm) of the ramp phase of the concurrent TPN/insulin infusionremaining, as indicated by the position of the Infusion Progressionindicator 706 and the value of the Ramp Phase Time Remaining indicator712. The Infusion Phase indicator 701 displays the current phase of theconcurrent TPN/insulin infusion as the ramp phase. The values presentedin the TPN Infusion portion 740 and the Insulin Infusion portion 760 areupdated for the present time in the concurrent TPN/insulin infusion.

Referring to FIG. 7C, this example shows the user interface 200 at thebeginning of the continuous phase of the concurrent TPN/insulininfusion, as indicated by the position of the Infusion Progressionindicator 706, the value (0:00) of the Ramp Phase Time Remainingindicator 712, and the value (12:00) of the Continuous Phase TimeRemaining indicator 722. The Infusion Phase indicator 701 displays thecurrent phase of the concurrent TPN/insulin infusion as the continuousphase. The values presented in the TPN Infusion portion 740 and theInsulin Infusion portion 760 are updated for the present time in thecontinuous phase.

Referring to FIG. 7D, this example shows the user interface 200 duringthe continuous phase of the concurrent TPN/insulin infusion, asindicated by the position of the Infusion Progression indicator 706 andthe value (5:13) of the Continuous Phase Time Remaining indicator 722.The VTBI values presented in the TPN Infusion portion 740 and theInsulin Infusion portion 760 are updated for the present time in thecontinuous phase. The dose values and rate values remain constant duringthe continuous phase.

FIGS. 7E-7H illustrate action by the user to titrate the insulin dose,through on the fly changes or hot titration. For example, when themeasured blood glucose levels of the patient are elevated above theoptimum range, the user 202 can increase the relative insulin infusion(units/L of TPN). Referring to FIG. 7E, the user 202 selects the InsulinDose indicator 766. Referring to FIG. 7F, the user interface 200displays a Desired Insulin Dose box 782 and entry keypad 784. Referringto FIG. 7G, the user 202 has entered the new desired insulin dose on theentry keypad 784 and the value of the new desired insulin dose (20units/L of TPN in place of the previous 10 units/L of TPN) appears inthe Desired Insulin Dose box 782. The user 202 selects a Start key 786to restart the concurrent TPN/insulin infusion. Referring to FIG. 7H,the Insulin Dose indicator 766 displays the value for the new desiredinsulin dose (20 units/L of TPN), and the Insulin Rate indicator 768 andthe Insulin VTBI indicator 770 display values of the insulin rate andthe insulin VTBI, respectively, automatically calculated for the newdesired insulin dose.

Referring to FIG. 7I, this example shows the user interface 200 duringthe continuous phase of the concurrent TPN/insulin infusion, asindicated by the position of the Infusion Progression indicator 706 andthe value (1:00) of the Continuous Phase Time Remaining indicator 722.The VTBI values presented in the TPN Infusion portion 740 and theInsulin Infusion portion 760 are updated for the present time in thecontinuous phase. The Insulin Dose indicator 766 continues to displaythe value for the new desired insulin dose (20 units/L of TPN). The dosevalues and rate values remain constant during the continuous phase.

Referring to FIG. 7J, this example shows the user interface 200 at thebeginning of the KVO phase of the concurrent TPN/insulin infusion, asindicated by the position of the Infusion Progression indicator 706, thevalue (0:00) of the Continuous Phase Time Remaining indicator 722, andthe value (until stopped) of the KVO Phase Time Remaining indicator 732.The Infusion Phase indicator 701 displays the current phase of theconcurrent TPN/insulin infusion as the KVO phase. The values presentedin the TPN Infusion portion 740 reflect the End of Infusion Actionselected, i.e., the Keep Vein Open (KVO) option with a rate value of onemL/hr displayed in the TPN Dose Rate indicator 748. The TPN VTBIindicator 750 displays KVO to indicate that the KVO phase will continueuntil stopped. The values presented in the Insulin Infusion portion 760include the new desired insulin dose (20 units/L of TPN) from theprevious continuous phase in the Insulin Dose indicator 766, and valuesof zero for the Insulin Rate indicator 768 and the Insulin VTBIindicator 770 to indicate that no insulin infusion is being performedduring the KVO phase.

Those skilled in the art will appreciate that the concurrent TPN/insulininfusion can include different phases as desired for a particularapplication. The concurrent TPN/insulin infusion can include TPN ramp,TPN continuous, TPN taper, and/or KVO phases, and combinations thereof.The example of FIG. 7J concludes with a KVO phase. In another example,the concurrent TPN/insulin infusion can conclude with a TPN taper. Thoseskilled in the art will appreciate that the various phases can be ofdifferent durations, which can be input or are selectable by the user202 via the user interface 200.

FIG. 8 is a flowchart of a method for concurrently administering a TPNsolution and an insulin solution in accordance with the presentinvention. In one embodiment, the method 800 can be performed using theinfusion system 100 illustrated in FIG. 1.

Referring to FIG. 8, the method 800 can concurrently administer to apatient a TPN solution from a TPN source and an insulin solution from aninsulin source. The method 800 includes: providing a disposable cassette810 having a primary line, a secondary line, and a common outlet, theprimary line and the secondary line being in fluid communication withthe common outlet; connecting the TPN source to the primary line 820;connecting the insulin source to the secondary line 830; placing thecommon outlet in fluid communication with the patient 840; driving theTPN solution through the primary line 850 at a TPN dose rate; drivingthe insulin solution through the secondary line 860 at an insulin doserate; mixing the TPN solution and the insulin solution in the disposablecassette to generate an infusion mixture before the common outlet 870;varying at least one of the TPN dose rate and the insulin dose rate 880to vary a ratio of TPN solution to insulin solution in the infusionmixture; and administering the infusion mixture to the patient 890.

The varying at least one of the TPN dose rate and the insulin dose rate880 can provide a TPN ramp phase, a TPN continuous phase, a TPN taperphase, and/or a TPN Keep Vein Open (KVO) phase during the concurrentTPN/insulin infusion as desired for a particular application.

To generate the TPN ramp phase, such as can be used at the beginning ofthe concurrent TPN/insulin infusion, the method 800 can include rampingthe TPN dose rate from zero to a continuous phase TPN dose rate. Anexemplary TPN ramp phase is illustrated at Ramp portion 610 of FIG. 6.In one embodiment, the method 800 can maintain the insulin dose rate atzero during the TPN ramp phase. In another embodiment, the method 800can maintain the insulin dose rate at a selected fraction of the TPNsolution flow rate during the TPN ramp phase. In yet another embodiment,the method 800 can maintain the insulin dose rate at a continuous phaseinsulin dose rate during the TPN ramp phase.

To generate the TPN continuous phase, which maintains the TPN dose rateconstant, the method 800 can include maintaining the TPN dose rate at acontinuous phase TPN dose rate and maintaining the insulin dose rate ata selected fraction of the continuous phase TPN dose rate. An exemplaryTPN continuous phase is illustrated at Continuous portion 620 of FIG. 6.Those skilled in the art will appreciate that the insulin dose rate canbe adjusted during the TPN continuous phase as desired to manually orautomatically adjust for measured glucose levels of the patient.

To generate the TPN taper phase, such as can be used at the end of theconcurrent TPN/insulin infusion, the method 800 can include tapering theTPN dose rate from a continuous phase TPN dose rate to a TPN dose rateof zero. An exemplary TPN taper phase is illustrated at TPN Taper option306 of FIG. 3A. In one embodiment, the method 800 can includemaintaining the insulin solution dose rate at zero during the TPN taperphase. In another embodiment, the method 800 can include maintaining theinsulin solution dose rate at a selected fraction of the TPN solutiondose rate to maintain the ratio of the TPN solution to the insulinsolution as constant during the TPN taper phase. In yet anotherembodiment, the method 800 can include maintaining the insulin solutiondose rate at a continuous phase insulin and dose rate during the TPNtaper phase.

To generate the TPN Keep Vein Open (KVO) phase, such as can be used atthe end of the concurrent TPN/insulin infusion, the method 800 caninclude decreasing the TPN dose rate from a continuous phase TPN doserate to a Keep Vein Open (KVO) TPN dose rate. An exemplary TPN KVO phaseis illustrated at KVO portion 630 of FIG. 6. Those skilled in the artwill appreciate that the various phases can be of different durations,which can be input or are selectable by the user 202 via the userinterface 200.

The method 800 can include the user adjusting the insulin flow rate onthe fly, i.e., as the concurrent TPN/insulin infusion proceeds, asillustrated in FIGS. 7E-7H. When the insulin dose rate of the drivingthe insulin solution through the secondary line 860 at an insulin doserate is a first insulin dose rate, the method 800 can include drivingthe insulin solution at a second insulin dose rate in response to inputof the second insulin dose rate by a user. The second insulin dose ratecan adjust for measured glucose levels of the patient.

To avoid hyperglycemia or hypoglycemia in the patient, the method 800can include monitoring glucose level in the patient and adjusting theinsulin dose rate in response to the monitored glucose level. In oneembodiment, the method 800 can include changing the insulin dose ratefrom a first insulin dose rate to a second insulin dose rate in responseto the monitored glucose level. In one embodiment, a glucose sensor canprovide the monitored glucose level to an insulin therapy calculationsystem or algorithm, which then automatically programs (auto-programs orauto-populates) the flow controller and populates the user interfacewith updated delivery parameters, such as rate, volume and duration, andthe like.

To allow the user to monitor progress of the concurrent TPN/insulininfusion, the method 800 can include displaying planned values of theTPN dose rate and the insulin dose rate as a function of time on aTPN/Insulin Infusion Plot, and optionally displaying an InfusionProgression indicator at a present infusion time on the TPN/InsulinInfusion Plot. An exemplary TPN/Insulin Infusion Plot is illustrated atTPN/Insulin Infusion Plot portion 700 of FIG. 7A. The TPN/InsulinInfusion Plot portion can include a TPN Infusion profile and an InsulinInfusion profile. In one embodiment, the method 800 can includedisplaying an infusion portion selected from the group consisting of aRamp portion, a Continuous portion, a Taper portion, and a KVO portion.

Another embodiment of the invention is shown in FIG. 9. In thisembodiment, a method 900 is shown to concurrently deliver a TPN solutionfrom a TPN source container and an insulin solution from an insulinsource container that is separate from the TPN source container. Themethod 900 includes, in step 910, providing a fluid administration sethaving a primary line, a secondary line, a common outlet line, and apumping/mixing chamber located between and in fluid communication withthe primary line, the secondary line and the common outlet line. Themethod 900 includes, in step 920, connecting the primary line to the TPNsource container and, in step 930, connecting the secondary line to theinsulin source container. The method 900 further includes, in step 940,selectively allowing the primary line to feed TPN solution from theprimary line to the pumping/mixing chamber and, in step 950, selectivelyallowing the secondary line to feed insulin solution to thepumping/mixing chamber. The method 900 includes, in step 960, mixing theTPN solution and the insulin solution in the pumping/mixing chamber togenerate an infusion mixture before the common outlet line. The method900 further includes, in step 970, driving with a positive displacementpumping mechanism the TPN solution from the pumping/mixing chamberthrough the common outlet line at a TPN dose rate, and concurrently withsaid driving the TPN solution step, in step 980, driving with thepositive displacement pumping mechanism the insulin solution from themixing chamber through the common outlet line at an insulin dose rate.The method 900 also includes, in step 990, varying at least one of theTPN dose rate and the insulin dose rate to vary a ratio of TPN solutionto insulin solution in the infusion mixture.

While the embodiments of the invention disclosed herein are presentlyconsidered to be preferred, various changes, rearrangement of steps, andmodifications can be made without departing from the scope of theinvention. The scope of the invention is indicated in the appendedclaims, and all changes that come within the meaning and range ofequivalents are intended to be embraced therein.

The invention claimed is:
 1. An infusion system for use with a totalparenteral nutrition (“TPN”) source of TPN solution and an insulinsource of insulin solution to provide concurrent TPN/insulin infusion,the infusion system comprising: a fluid administration set having aprimary line in fluid communication with the TPN source, a secondaryline in fluid communication with the insulin source, and a common outletline connected to and in operative fluid communication with the primaryline and the secondary line; a positive displacement pump operable toremovably receive the fluid administration set, the pump having a drivemechanism being operable on the fluid administration set to concurrentlymove the TPN solution through the primary line to the outlet line inresponse to a TPN solution flow rate signal and the insulin solutionthrough the secondary line to the outlet line in response to an insulinsolution flow rate signal; a flow controller configured to provide theTPN solution flow rate signal and the insulin solution flow rate signalto the drive mechanism of the pump, wherein the flow controller isfurther configured to vary the TPN solution flow rate signal and theinsulin solution flow rate signal to vary a ratio of TPN solution toinsulin solution provided to the common outlet; a glucose sensoroperably connected to the patient to monitor glucose level and furtheroperable connected to the flow controller; and wherein the flowcontroller comprises instructions that when executed are configured to:display a first user interface including a plurality of user selectablemodes for concurrent TPN/insulin infusion, wherein the plurality of userselectable modes comprise continuous phase, taper phase, and keep veinopen phase, display a second user interface that is customized based ona first user selection of one of the user selectable modes in the firstuser interface; display a third user interface that includes insulininfusion options, said insulin infusion options configured to enableindependent titration of insulin delivery or link the insulin deliveryto TPN delivery; and display a fourth user interface that illustratesTPN infusion profile and insulin infusion profile on a same timeline,said fourth user interface including a start key configured to initiatethe concurrent TPN/insulin infusion; wherein the flow controller isfurther configured to automatically control the insulin solution flowrate signal while the TPN solution is being delivered based on themonitored glucose level.
 2. The infusion system of claim 1 wherein theflow controller is further operable to ramp the TPN solution flow ratesignal from a value corresponding to a TPN dose rate of zero to a valuecorresponding to a continuous phase TPN dose rate over a user selectableduration in a TPN ramp phase.
 3. The infusion system of claim 2 whereinthe flow controller is further operable to maintain the insulin solutionflow rate signal at a value corresponding to an insulin dose rate ofzero during the TPN ramp phase.
 4. The infusion system of claim 2wherein the flow controller is further operable to maintain the insulinsolution flow rate signal as a selected fraction of the TPN solutionflow rate signal during the TPN ramp phase.
 5. The infusion system ofclaim 2 wherein the flow controller is further operable to maintain theinsulin solution flow rate signal at a value corresponding to acontinuous phase insulin dose rate during the TPN ramp phase.
 6. Theinfusion system of claim 1 wherein the flow controller is furtheroperable to maintain the TPN solution flow rate signal at a valuecorresponding to a continuous phase TPN dose rate and to maintain theinsulin solution flow rate signal at a selected fraction of the TPNsolution flow rate signal during the TPN continuous phase.
 7. Theinfusion system of claim 1 wherein the flow controller is furtheroperable to taper the TPN solution flow rate signal over a userselectable duration from a value corresponding to a continuous phase TPNdose rate to a value corresponding to a TPN dose rate of zero during TPNtaper phase.
 8. The infusion system of claim 7 wherein the flowcontroller is further operable to maintain the insulin solution flowrate signal at a value corresponding to an insulin dose rate of zeroduring the TPN taper phase.
 9. The infusion system of claim 7 whereinthe flow controller is further operable to maintain the insulin solutionflow rate signal as a selected fraction of the TPN solution flow ratesignal to maintain the ratio of the TPN solution to the insulin solutionconstant during the TPN taper phase.
 10. The infusion system of claim 7wherein the flow controller is further operable to maintain the insulinsolution flow rate signal at a value corresponding to a continuous phaseinsulin dose rate during the TPN taper phase.
 11. The infusion system ofclaim 1 wherein the flow controller is further operable to decrease theTPN solution flow rate signal over a user selectable duration from avalue corresponding to a continuous phase TPN dose rate to a valuecorresponding to a Keep Vein Open (KVO) TPN dose rate after a TPNcontinuous phase.
 12. The infusion system of claim 1 wherein the flowcontroller is further operable to vary the insulin solution flow ratesignal from a first insulin solution flow rate signal to a secondinsulin solution flow rate signal in response to input of the secondinsulin solution flow rate signal by a user.
 13. The infusion system ofclaim 1 wherein the flow controller is further operable to vary theinsulin solution flow rate signal from a first insulin solution flowrate signal to a second insulin solution flow rate signal in response tothe glucose signal.
 14. The infusion system of claim 1 wherein the userinterface is further operable to display an Infusion Progressionindicator on the TPN/Insulin Infusion Plot portion, the InfusionProgression indicator being operable to indicate a current state of theconcurrent TPN/insulin infusion.
 15. The infusion system of claim 1wherein the user interface is further operable to display an infusionportion selected from the group consisting of a Ramp portion, aContinuous portion, a Taper portion, and a KVO portion.
 16. The infusionsystem of claim 1 wherein the administration set comprises a cassetteincluding a primary inlet joining a primary fluid passageway into fluidcommunication with the primary line, a secondary inlet joining asecondary fluid passageway into fluid communication with the secondaryline, an outlet in fluid communication with the outlet line, and apumping/mixing chamber covered by a resilient flexible membrane and influid communication with the primary fluid passageway, the secondaryfluid passageway and the outlet.
 17. The infusion system of claim 16wherein the drive mechanism comprises a motor driving a plunger into themembrane covering the pumping/mixing chamber while operating a primaryinlet valve, a secondary inlet valve and an outlet valve so as to mixand displace fluid from the pumping/mixing chamber through the outletinto the outlet line.